- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01440673
Aprepitant for Postoperative Nausea and Vomiting in Laparoscopic Hysterectomy
September 23, 2011 updated by: Wol Seon Jung, Gachon University Gil Medical Center
- Gynecological surgery is associated with a high incidence of postoperative nausea and vomiting.
- NK1 receptor antagonists such as aprepitant appear to be highly effective for treating acute and delayed emesis, and yet understanding of the efficacy of different doses of aprepitant is limited.
- We performed a prospective, randomized, double-blinded placebo-controlled study of 123 female adults scheduled for laparoscopic hysterectomy who received 80 mg aprepitant, 125 mg aprepitant, or a placebo.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
123 female patients (ages 21-60) undergoing laparoscopic hysterectomy
- 80mg aprepitant
- 125mg aprepitant
- placebo
Incidences of nausea, vomiting/retching, and use of rescue antiemetics were recorded at 0, 1, 2, 24, and 48 h after surgery.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Inchon, Korea, Republic of, 405-760
- Gil Medical Center Gachon University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- female laparoscopic hysterectomy isoflurane anesthesia postoperative opioid use
Exclusion Criteria:
- liver disease neurologic disease active pulmonary disease cardiac arrhythmia allergies to any perioperative medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: aprepitant 125mg
NK1 receptor antagonist
|
Aprepitant 80 mg, Aprepitant 125 mg
|
Active Comparator: Aprepitant 80 mg
|
Aprepitant 80 mg, Aprepitant 125 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The numbers (and percentages) of patients who experienced complete response
Time Frame: 48 hours postoperatively
|
|
48 hours postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: WOL SEON JUNG, M.D. Ph.D., Gil Medical Center Gachon University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
September 20, 2011
First Submitted That Met QC Criteria
September 23, 2011
First Posted (Estimate)
September 26, 2011
Study Record Updates
Last Update Posted (Estimate)
September 26, 2011
Last Update Submitted That Met QC Criteria
September 23, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Neurokinin-1 Receptor Antagonists
- Aprepitant
Other Study ID Numbers
- GIRBA2085
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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